BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    THERMOSUIT SYSTEM

    K Number: K061023 · Decision Sep 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    160

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    Basic Information

    Device Name
    THERMOSUIT SYSTEM
    K Number
    K061023
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life Recovery Systems Hd, LLC
    Date Received
    April 13, 2006
    Decision Date
    September 20, 2006
    Product Code
    NZE
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NZE Hyperthermia Monitor

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